UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028096
Receipt No. R000032113
Scientific Title The Association with Geriatric Nutritional Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Date of disclosure of the study information 2017/07/24
Last modified on 2018/01/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Acronym The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Scientific Title The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Scientific Title:Acronym The Association with Geriatric Nutritional
Risk Index, ADL, and Clinical Outcomes in Patients on Chronic Hemodialysis.
Region
Japan

Condition
Condition End-stage renal disease, Sarcopenia, Hypertension, Dyslipidemia, Diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics Orthopedics
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the association with GNRI(Geriatric Nutritional Risk Index) and the ability of walking, which patient can walk by oneself or not, and mortality from all causes in HD patients.
Basic objectives2 Others
Basic objectives -Others Association with GNRI and the ability of walking
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Can walk by oneself or not.
Key secondary outcomes Mortality from all causes, Incidence of bone fracture and hospitalization, Change of BBS(Berg Balance Scale), TUG(Timed Up to Go), 10 meter Walking Test, and FIM(Function Independence Measure).

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who underwent HD in Sugitagenpakukinen Kouritu Obama Hospital between April 1st 2011 and March 31st 2016.
2.Patients who underwent whole bone densitometry.
3.Age : Not applicable
4.Gender : Not applicable
5.Duration of HD/Primary disease of HD : Not applicable
Key exclusion criteria 1.Patients who, started HD during this observation period, died of senility within 3 months after the HD started.
2.Patients who, started HD before this observation period, died of senility within May 30th 2011.
3.Patients who were read to be ineligible by principal investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokuharu Tanaka
Organization Sugitagenpakukinen Kouritu Obama Hospital
Division name Department of Internal Medicine
Zip code
Address 2-2 Oote-cho, Obama-shi, Fukui, Japan
TEL 0770-52-0990
Email tnktya@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tokuharu Tanaka
Organization Sugitagenpakukinen Kouritu Obama Hospital
Division name Department of Internal Medicine
Zip code
Address 2-2 Oote-cho, Obama-shi, Fukui, Japan
TEL 0770-52-0990
Homepage URL
Email tnktya@gmail.com

Sponsor
Institute Sugitagenpakukinen Kouritu Obama Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 09 Month 30 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information 1. Study Design
Retrospective Cohort Study
2. Key inclusion criteria
1) Patients who underwent HD in Sugitagenpakukinen Kouritu Obama Hospital between April 1st 2011 and March 31st 2016.
2) Patients who underwent whole bone densitometry.
3) Age: Not applicable
4) Gender: Not applicable
5) Duration of HD/Primary disease of HD: Not applicable
3. Observation issue
1)Baseline Characteristics: patient's initials, gender, birth date, height, weight, complication, past history, medical record, medication history.
2) Patient's ADL
3)Biochemical test:Alb, Cre, TP, T-Cho, CRP
4) Whole bone densitometry: lean tissue mass (upper & lower limb)
5) BBS (Berg Balance Scale), TUG (Timed Up to Go), 10 meter walking test, FIM (Functional Independence Measure)

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2018 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.